WASHINGTON (Reuters) - Two television commercials for Bayer AG’s birth control product Yaz are misleading, U.S. health regulators warned the company in a letter released on Tuesday.
The ads suggest the pills are approved for a wider-range of conditions such as premenstrual syndrome, the U.S. Food and Drug Administration said in a letter dated Oct 3. The ads also minimize the drug’s risks, the agency said.
One commercial featured women singing “We’re not gonna take it” and kicking, punching and pushing balloons with words such as “irritability,” “moodiness” and “bloating.”
Those symptoms are common with PMS. Yaz, however, is cleared for a more serious condition called premenstrual dysphoric disorder (PMDD), which causes anxiety, tension, persistent anger and other symptoms.
“The TV ads misleadingly suggest that Yaz is approved to treat women with any severity of the symptoms presented, regardless of whether their symptoms are actually severe enough to constitute PMDD,” the FDA letter said.
A second ad featured the song “Good-Bye to You” with women releasing balloons labeled with symptoms. The commercial suggests “women are saying ‘goodbye’ to their symptoms and are now symptom-free, when such an elimination of symptoms has not been demonstrated by substantial evidence or substantial clinical experience,” the FDA said.
Both commercials also “suggest that Yaz is approved for acne of all severities when this is not the case,” the agency said.
A Bayer spokeswoman could not immediately be reached for comment.
The letter was posted on the FDA Websitehere.
Reporting by Susan Heavey and Lisa Richwine, editing by Leslie Gevirtz, Bernard Orr
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